MAUDE Adverse Event Report: BELIMED AG MST-V 6-0-12 VS1; STERILIZER

Lot Number	2013584
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of the incident, the docking plates for the batch carts were misaligned with the height of the carts, making it impossible to easily roll the racks out of the sterilizer and onto the carts as intended.The misalignment was not due to nonconforming or faulty parts.Sterilizer docking plate height has been readjusted and testing was carried out to ensure smooth transition of racks from the sterilizer to the cart.
Event or Problem Description
The spd manager reported that an employee's shoulder was injured while trying to lift a sterilizer rack from the chamber onto the transport cart.The employee went to the emergency department to get checked out but was not hospitalized.As of (b)(6) 2024 the employee has not returned to work and is not able to drive nor to lift their arm.The incident is being handled by the facility's occupational care and the injured individual is currently awaiting an mri.

• Brand Name: MST-V 6-0-12 VS1
• Common Device Name: STERILIZER
• Manufacturer (Section D): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer (Section G): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer Contact: heidi friesacher ; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• MDR Report Key: 20219482
• Report Number: 3001061128-2024-00004
• Device Sequence Number: 7801199
• Product Code: FLE
• UDI-Device Identifier: 07640141626153
• UDI-Public: (01)07640141626153(11)210506
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K090339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 09/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Lot Number: 2013584
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown